MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET; FAD STENT, URETERAL

Catalog Number UNKNOWN

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Hematuria (2558); Dysuria (2684)

Event Date 04/04/2015

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Song 2015, complications after polymeric and metallic ureteral stent placements including three types of fistula.Patient with a resonance stent presented with intractable flank pain and hematuria.These persons required a surgical or other procedure to remove the stents.The patient with a resonance stent had a history of retroperitoneal fibrosis, and he complained of dysuria, intermittent hematuria, and flank pain.We performed simple balloon dilation and inserted an 8f pus after ballooning, which was removed 4 weeks after insertion.Note: per table 1 stenting duration is 20 months without previous surgery and there is no mention in the study that the stent was replaced after the recommended 12 months balloon dilation with stent removal.

Manufacturer Narrative

Device evaluation this complaint was opened to address the adverse events related to the use of the rms stent, as reported by the study song, 2015, ¿complications after polymeric and metallic ureteral stent placements including three types of fistula¿.The rms device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Document review manufacturing records review could not be completed as the lot number is unknown.However, prior to distribution all rms devices are subject to visual a visual inspection and functional checks to ensure device integrity.Review of historical data: historical data was not reviewed as the lot number is unknown.It should be noted that the instructions for use (ifu0020) states the following: "the stent must not remain indwelling more than 12 (twelve) months.If patient's status permits, the stent may be replaced with a new stent".Furthermore, it should be noted that the potential adverse events associated with indwelling ureteral stents are listed in the ifu: ¿fistula formation, dysturia, hematuria, pain/discomfort¿ there is evidence to suggest that the customer did not follow the instructions for use.Image review an image was not returned for evaluation.Root cause review a definitive root cause of user error was identified based on the available information.In the study, there is no mention that the stent was replaced after the recommended 12 months as per the instructions for use.This is considered user error.It should be noted that, as the device was used outside of its validated state and/or against the instructions provided in the ifu, it is therefore not possible to predict how the devices will perform or function.Exceeding stent indwell period may have caused or contributed to the pain, hematuria and dysturia experienced by the patient, as reported by the study.Summary this complaint was opened to address the adverse events related to the use of the rms stent, as reported by the study song, 2015, ¿complications after polymeric and metallic ureteral stent placements including three types of fistula¿.User error was identified as the definitive root cause as the stent exceeded the indwell period of 12 months.Complaint is confirmed based on customer and/or rep testimony.According to the initial reporter, the patient required a surgical (or other) procedure to remove the stent.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 27-jan-2023.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 15409601
• MDR Text Key: 299767766
• Report Number: 3001845648-2022-00631
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/04/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male